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Home-based supervised physical activity has no major impact on fatigue and quality of life for patients with metastatic cancer receiving oral targeted therapy.
Among patients with metastatic cancer who are receiving oral targeted therapy, home-based supervised physical therapy has been shown to be feasible but it has no major impact on fatigue and quality of life compared with recommended adapted physical activity with a booklet, study results have shown.
Findings from the AFSOS-Unicancer QUALIOR study were presented at the 2025 European Society for Medical Oncology (ESMO) Congress by Florence Joly Lobbedez, MD, phD, of the medical oncology department at Centre Francois Baclesse in Caen, France.
FACT-F score: a number that helps doctors understand how a patient is feeling and how cancer and its treatment are affecting their life.
ECOG performance status: a measure of patients’ ability to complete daily tasks, with a lower score indicating greater independence.
“In conclusion, this is one of the few randomized studies conducted in patients with metastatic cancer, and the first one focused on patient treated with oral targeted therapy treatments,” Lobbedez said during the congress. “A home-based supervised physical activity program in this population is feasible. Our primary endpoint was not met, and we didn't see some statistically significant difference with the other quality of life questionnaire. However, the patient in the program increased their physical activity level and report better trajectory with the visual analogue scale of fatigue and energy.”
Following up on phase 2 data presented at ESMO in 2021 that showed that the program was feasible, phase 3 results presented this year showed that among 190 patients who were randomized — 126 of whom underwent supervised physical activity and 64 of whom were in the control arm — and 128 who were analyzed, no difference in FACT-F score was observed at three months. While at three months fewer patients in the supervised physical activity arm reported visual analogue scale loss of energy (45% vs 62%), and no longitudinal differences in health-related quality of life, cognition, anxiety and depression were observed between the 2 arms, it was reported.
Noting that the study was under-powered due to what she described as difficulties with human resources, Lobbedez concluded her presentation by calling for further research on this topic.
“We need other clinical trials if we really want to definitively conclude if this type of program at home for metastatic patients [with cancer] is viable and efficient,” she said.
“Oral targeted therapy is nowadays largely prescribed to treat patients with metastatic cancer,” Lobbedez said. “It is widely used for a mixed range of cancer, but the main side effect induced by this treatment is fatigue, and there is some impact on patient compliance to treatment and deterioration in quality of life [as a result]. In parallel, we know that physical activity is beneficial, and we have many studies that show us now that we can reduce fatigue with physical activity and improve quality of life, but most studies are realized among patients who have localized cancer. And in fact, there are few studies conducted among patients with metastatic cancer, and the results are really mitigated. So that's why we designed this study.”
In the study, patients’ median age was 58 in the supervised physical activity arm and 59 in the control arm. In the respective arms, 87% and 89% of patients were female, and most patients had an ECOG performance status of 0. Most patients had metastatic breast cancer, were treated with a CDK inhibitor and were receiving their first line of metastatic treatment.
The study was conducted from July 2017 to July 2023, according to Lobbedez’s presentation. Patients in the experimental supervised physical activity arm participated in a program developed by specialized coaches involved in physical activity and cancer and trained for the trial. The program included one standardized at-home supervised session with a specialized coach and two non-supervised sessions every week for 3 months, and intensification of the program was possible, according to patients’ progression, and follow-up and progression were reported in a standardized grid. On the other hand, patients in the control arm received a booklet containing advice about exercise.
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